This study will investigate the validity of the HOGAR EEG/PSG monitoring kit designed by Bitbrain as a tool for characterizing and assessing cognitive function in older adults, as well as for detecting and predicting cognitive decline. The kit consists of two EEG headbands and a mobile computing device that allows measurements of sleep patterns (PSG) and brain activity (EEG) in a home environment.
Native Spanish speaker.
Agree to the examination procedures and tests.
Ability to involve a close family member or friend for functional evaluation.
Normal or corrected-to-normal color vision.
None
Our goal is to assemble a diverse sample representing different cognitive impairment levels to validate our developed home kit for effective quantification and prediction of decline. The sample comprises four groups categorized by cognitive level, aiming for gender and age balance. 1. MILD DEMENTIA: Diagnosed individuals (150) with mild dementia (GDS 4 or CDR 1). Moderate and severe cases (GDS 5-7) are excluded, including Alzheimer's, vascular, or mixed dementia. 2. MILD COGNITIVE IMPAIRMENT: Diagnosed patients (150) with mild cognitive impairment (GDS 3 or CDR 0.5). 3. SUBJECTIVE COGNITIVE DECLINE: Individuals reporting memory complaints (100) without objective impairment (GDS 2 or CDR 0). 4. NO IMPAIRMENT: Individuals without cognitive issues (100), serving as a control group (GDS 1 or CDR 0). Balanced recruitment from family members or advertisements.
Cohort
Cross-sectional
Home Lab
DeviceThe main goal is to comprehensively assess the cognitive and behavioral status of all participants, regardless of their assigned groups. Validated clinical tests (considered the gold standard) will be used, with measurements taken at participants' homes using a biosignal monitoring kit-the focal tool of the project. Whether in the control or specific groups, all participants will undergo an identical battery of tests in both the laboratory and home settings. The study design includes an introductory session for participants to understand the study's purpose and sign informed consent. Following consent, participants will have three sessions within a 3 to 6-week timeframe: one for autonomous technology use instruction and the other two for cognitive and functional evaluations.
Validation of HoGar
Validation of an Instrument for Objective and Automated Quantification of Cognitive Function in Older Adults Using Devices for Autonomous Home Use.
Identification of Diagnostic Patterns for Cognitive Impairment Severity Using Home Biosignal Measures.
Utilizing Home Biosignal Measures to Identify Patterns for the Diagnosis of Cognitive Impairment (Including Severity), Distinguishing Them from Those Without Cognitive Impairment (Concurrently Testing the Instrument's Validity).
Predictive Identification of Cognitive Decline and Transitions Using Home Biosignal Measures and Longitudinal Health Data
Identification of Patterns Using Home Biosignal Measures and Longitudinal Health Data to Predict Cognitive Decline and Transitions from Mild Cognitive Impairment to Moderate/Severe Cognitive Impairment or Dementia (Testing the Predictive Validity of the Instrument)
Click on the lead sponsor to view all of their trials.
Bitbrain
Lead sponsor
Hospital Miguel Servet
Collaborator
Hospital Provincial Nuestra Señora de Gracia
Collaborator
Hospital Clínico Zaragoza
Collaborator
Universidad de Zaragoza
Collaborator
Instituto de Investigación Sanitaria Aragón
Collaborator
